BIOTX Limited

Compensation

Full Description

Overview We are a single-product medical device developer seeking a dedicated and detail-oriented Compliance Officer to join our team on a remote basis. The ideal candidate will be thoroughly familiar with ISO13485 standards and FDA and EU MDR regulations affecting the design and manufacture of medical devices. Our dream candidate will be able to help us on-board a new eQMS, assist in building a compliant Design History File and will play a crucial role in ensuring that our organization adheres to all necessary industry regulations and standards. This position requires a strong background in quality management systems and the ability to conduct thorough quality audits, especially with regard to our Contract Management (CM) partner where all production is to be carried out. The Compliance Officer will collaborate with various departments within the CM to monitor their adherence to essential processes and procedures and to enforce compliance and continuous improvement. Responsibilities • Develop, implement, and maintain compliance programs that align with regulatory requirements and industry standards including overall responsibility for implementation of the eQMS. • Conduct regular quality audits to assess compliance with ISO 13485, FDA and EU MDR regulations. • Oversee quality control processes to ensure products meet established specifications and standards. • Collaborate with Contract Manufacturing teams to identify areas for improvement in quality systems and processes. • Perform quality inspections and assessments to ensure adherence to quality assurance protocols. • Manage documentation related to compliance activities, including audit reports and corrective action plans. • Provide training and support to staff on compliance-related matters and best practices. • Analyze data related to compliance metrics and prepare reports for management review. Skills • Strong knowledge of ISO 13485, FDA regulations, and EU MDR for medical devices. • Experience in conducting quality audits and implementing electronic quality management systems. • Proficient in quality control, quality inspection, and quality assurance methodologies. • Familiarity with QA/QC processes within a manufacturing environment. • Excellent project management skills with the ability to manage multiple tasks effectively. • Strong analytical skills for data analysis and problem-solving. • Effective communication skills for collaboration across departments. • Join us in ensuring the highest standards of compliance within our organization while contributing to our commitment to quality excellence. Job Types: Part-time, Permanent Pay: $20.00 - $35.00 per hour Expected hours: 5 – 10 per week Benefits: • Flexible schedule Education: • Bachelor's (Required) Experience: • QMS compliance regarding medical device manufacturing: 4 years (Preferred) Work Location: Remote